Additive Anti-inflammatory Action for Aortopathy & Arteriopathy
NCT ID: NCT04398992
Last Updated: 2026-02-09
Study Results
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Basic Information
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RECRUITING
10000 participants
OBSERVATIONAL
2016-01-01
2030-12-31
Brief Summary
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Twenty Chinese cardiovascular centers have collaborated to create a multicenter observational registry (named Chinese registry of Additive Anti-inflammatory Action for Aortopathy \& Arteriopathy \[5A\]), with consecutive enrollment of adult patients who underwent surgery for AAS that was started on Jan 1, 2016 and will be ended on December 31, 2040. Specially, the impact of inflammation and anti-inflammatory strategies on the early and late adverse events are investigated. Primary outcomes are severe systemic inflammatory response syndrome (SIRS), multiple organ dysfunction syndrome (MODS), Sequential Organ Failure Assessment (SOFA) scores at 7 days following this current surgery. Secondary outcomes are SISR, 30-day mortality, operative mortality, hospital mortality, new-onset stroke, acute kidney injury, surgical site infection, reoperation for bleeding, blood transfusion and length of stay in the intensive care unit.
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Detailed Description
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Currently, surgery is considered the best treatment option for patients with AAS. In addition to systemic inflammatory responses triggered by AAS itself, however, procedural factors including surgical trauma, anesthesia, cardiopulmonary bypass, hypothermia, circulatory arrest, and blood transfusion as well as mechanical ventilation initiated a cascade of inflammation, which further exacerbates "inflammatory storm", and is associated with significant postoperative mortality and morbidity. Along with surgical evolutions, scientists have made new discoveries and achievements in the underlying mechanism and understanding of inflammation of AAS, which greatly encourage us to optimize treatment for these patients. Going beyond traditional surgery, anti-inflammatory action is crucially important to target the residual cardiovascular risk by specific anti-inflammatory interventions as a crucially adjunct therapeutic strategy to improve the well-being of patient.
A better understanding of the interaction between patient's inflammatory responses and anti-inflammatory strategies which may limit the residual cardiovascular risk is essential for the development of novel preventive, diagnostic, and therapeutic approaches, providing a critical pathophysiological insight into the role of inflammation in risk assessment and anti-inflammatory targeting. The epidemiological observation that biomarkers of inflammation are associated with clinical cardiovascular risk supports the theory that targeted anti-inflammatory treatment appears to be a promising strategy in reducing residual cardiovascular risk on the background of traditional surgical repair as well as basic therapy. Previous researches have shown that ulinastatin used in cardiac surgery may be effective in prevention of cardiovascular events through an anti-inflammatory effect. This residual inflammatory risk has increasingly become a viable therapeutic targeting on the background of validated surgical repair as well as basic medical therapy for AAS.
Although aortic dissection registries have been established during the last years, such as the International Registry of Acute Aortic Dissection (IRAD), the Nordic Consortium for Acute Type A Aortic Dissection (NORCAAD) Registry, German Registry for Acute Aortic Dissection type A (GERAADA), the Society of Thoracic Surgeon (STS) database , and European Registry of Type A Aortic Dissection (ERTAAD), there are currently no dedicated registry to prospective collections and characteristics of inflammatory responses, anti-inflammatory strategies, and clinical outcomes especially for AAS patients. We have established a multicenter research collaboration (named "Chinese Registry of Additive Anti-inflammatory Action for Aortopathy \& Arteriopathy \[5A\]") and planned a prospectively observational study to understand the patient's inflammatory responses, characterize the potential anti-inflammatory strategies, and evaluate clinical outcome and prognosis of AAS patients at 15 years in a large study of Chinese population.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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observation
Data were collected by a designed form. Statistic software was used to analyze clinical data.
Eligibility Criteria
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Inclusion Criteria
* Patients with diagnosis of AAS, including aortic dissection, penetrating aortic ulcer or intramural hematoma.
* Symptoms started within 14 days from surgery.
* Patients received medical therapy, open surgical, endovascular, or hybrid repair.
* Any other major cardiac surgical procedure concomitant with surgery for AAS, such as coronary artery bypass grafting or carotid artery replacement;
Exclusion Criteria
* Onset of symptoms \> 14 days from surgery.
* AAS secondary to traumatic or iatrogenic injury.
* Patients who declined participation in registration and follow-up investigation.
18 Years
ALL
No
Sponsors
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Beijing Anzhen Hospital
OTHER
Nanjing Medical University
OTHER
Responsible Party
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Hong Liu
Investigator of Department of Cardiac Surgery
Principal Investigators
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Hong-jia Zhang, MD
Role: STUDY_DIRECTOR
Beijing Anzhen Hospital
Hong Liu
Role: PRINCIPAL_INVESTIGATOR
Nanjing Medical University
Si-chong Qian
Role: PRINCIPAL_INVESTIGATOR
Beijing Anzhen Hospital
Locations
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Beijing Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Chongqing Hospital of Jiangsu Provincial People's Hospital
Chongqing, Chongqing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
QianXiNan People's Hospital
Xingyi, Guizhou, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Third Affiliated Hospital of Soochow University
Changzhou, Jiangsu, China
Suqian Hospital of of Nanjing Medical University
Suqian, Jiangsu, China
Dongtai People's Hospital
Yancheng, Jiangsu, China
Subei People's Hospital of Jiangsu Province
Yangzhou, Jiangsu, China
the Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shanghai DeltaHealth Hospital
Shanghai, Shanghai Municipality, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
The Seventh Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The Friendship Hospital of Yili Kazak Autonomous Prefecture
Yining, Xinjiang, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Beijing Anzhen Hospital Capital Medical University
Beijing, , China
Beijing Chaoyang Hospital
Beijing, , China
the First Affiliated Hospital of Bengbu Medical College
Bengbu, , China
Xiangya Hospital Central South University
Changsha, , China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
the First Affiliated Hospital of Guilin Medical College
Guilin, , China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, , China
Nanjing First Hospital, Nanjing Medical University
Nanjing, , China
the Affiliated Hospital of Qingdao University
Qingdao, , China
Shanghai East Hospital Tongji University
Shanghai, , China
the First Affiliated Hospital of Shantou University Medical College
Shantou, , China
Teda International Cardiovascular Hospital
Tianjin, , China
Tianjin Chest Hospital
Tianjin, , China
Xiamen Cardiovascular Hospital
Xiamen, , China
Countries
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Central Contacts
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Facility Contacts
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Yong Yao, MD
Role: primary
Chao Ma, MD
Role: backup
Sheng-rong Lin, MD
Role: primary
Cheng-bin Tang, MD
Role: primary
Zhi-hua Zeng, MD
Role: primary
Xin Zhao, MD
Role: primary
ZHIQIANG DONG, MD
Role: backup
ZHIWEI LI
Role: primary
ZHIWEI LI, MA
Role: backup
Lu Han, MD
Role: primary
References
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Liu H, Li HY, Li YL, Wu Y, Gu JX, Diao YF, Shao YF, Sun LZ, Qian SC, Zhang HJ; 5A Investigators. Operative Mortality After Type A Aortic Dissection Surgery: Differences Based on Sex and Age. JACC Adv. 2024 Mar 14;3(4):100909. doi: 10.1016/j.jacadv.2024.100909. eCollection 2024 Apr.
Liu H, Diao YF, Shao YF, Qian SC, Zeng ZH, Fan GL, Ma LY, Zhang HJ; on the behalf of the Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Investigators. Prognostic implication of residual inflammatory trajectories in acute type I aortic dissection: dual-center prospective cohort study. Int J Surg. 2024 Jun 1;110(6):3346-3356. doi: 10.1097/JS9.0000000000001245.
Liu H, Qian SC, Li HY, Shao YF, Zhang HJ; China Additive Anti-inflammatory Action for Aortopathy, Arteriopathy (5A) Investigators. Chinese Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Registry protocol: rationale, design and methodology. BMC Cardiovasc Disord. 2024 Feb 21;24(1):120. doi: 10.1186/s12872-024-03760-y.
Liu H, Sun BQ, Qian SC, Sun MY, Shao YF, Ding Y, Li H, Zhang HJ. Contemporary use and outcome of Cabrol shunt in type A aortic dissection surgery: insight from China 5A study. Open Heart. 2023 Dec 9;10(2):e002465. doi: 10.1136/openhrt-2023-002465.
Zhao HL, Tang ZW, Diao YF, Xu XF, Qian SC, Li HY, Shao YF, Zhao S, Liu H; on the behalf of the Additive Anti-inflammatory Action for Aortopathy, Arteriopathy (5A) Investigators. Inflammatory profiles define phenotypes with clinical relevance in acute type A aortic dissection. J Cardiovasc Transl Res. 2023 Dec;16(6):1383-1391. doi: 10.1007/s12265-023-10436-z. Epub 2023 Sep 15.
Other Identifiers
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5A-Plan
Identifier Type: -
Identifier Source: org_study_id
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